Data served as basis for recent FDA approval of
ruxolitinib cream (Opzelura™) 1.5% for the topical treatment of
nonsegmental vitiligo in adult and pediatric patients 12 years of
age and older
Fifty-two week data from the Phase 3 TRuE-V
clinical trial program demonstrate an increase in the proportion of
patients achieving repigmentation with longer duration of
ruxolitinib cream treatment1
Vitiligo is a chronic autoimmune disease
characterized by depigmentation of skin
Incyte (Nasdaq:INCY) today announced that data from the pivotal
Phase 3 TRuE-V clinical trial program evaluating ruxolitinib cream
(Opzelura™) 1.5% in patients 12 years of age and older with
nonsegmental vitiligo have been published in The New England
Journal of Medicine (NEJM). In the trials (TRuE-V1 and TRuE-V2),
application of ruxolitinib cream resulted in significant facial and
total body repigmentation versus vehicle-control as shown by
greater proportions of patients reaching the facial and total body
Vitiligo Area Scoring Index (F-VASI and T-VASI, respectively)
endpoints at Week 24 vs. vehicle, with a higher proportion of
patients responding at Week 521.
“Incyte is committed to developing innovative medicines for
people with immune-mediated dermatologic conditions, and the
publication of the TRuE-V results in NEJM is the culmination of
years of work to advance science in vitiligo where there were no
approved pharmacologic treatments for repigmentation,” said Jim
Lee, M.D., Ph.D., Group Vice President, Inflammation &
Autoimmunity, Incyte. “These pivotal results demonstrate
significant improvements in facial and total body repigmentation
with ruxolitinib cream, and we are proud that these data served as
the foundation for the recent approval of ruxolitinib cream as the
first and only U.S. Food and Drug Administration (FDA)-approved
treatment for repigmentation in nonsegmental vitiligo.”
Results from the Phase 3 TRuE-V studies vehicle-controlled
period (24 weeks) were previously announced, and Week 52 data were
featured in an oral presentation at the late-breaking abstract
session at the American Academy of Dermatology (AAD) Annual 2022
Meeting. Key findings from the studies include:
- Results at Week 24, which were consistent across both studies,
showed that approximately 30% of patients treated with ruxolitinib
cream achieved ≥75% improvement from baseline in F-VASI (F-VASI75),
the primary endpoint, while approximately 13% of patients applying
vehicle in one study achieved the primary endpoint. At Week 52,
approximately 50% of patients who received ruxolitinib cream from
Day 1 achieved F-VASI75.
- Additionally, at Week 24, more than 15% of patients treated
with ruxolitinib cream achieved ≥90% improvement from baseline in
F-VASI (F-VASI90) vs. approximately 2% of patients applying vehicle
met F-VASI90. At Week 52, the percentage of ruxolitinib
cream-treated patients who achieved F-VASI90 doubled to
approximately 30%.
- A greater proportion of patients at Week 52 achieved ≥50%
improvement in T-VASI (T-VASI50), and further improvement on
percentage change from baseline in facial body surface area (F-BSA)
with application of ruxolitinib cream was also observed.
In the vehicle-controlled period of the Phase 3 studies, the
most common adverse reactions (incidence ≥ 1%) were application
site acne, application site pruritus, nasopharyngitis, headache,
urinary tract infection, application site erythema, and
pyrexia2.
“The primary and key secondary analyses from the TRuE-V program
demonstrate the improvement in repigmentation possible with
ruxolitinib cream,” said David Rosmarin, M.D., Vice Chair of
Research and Education, Department of Dermatology at Tufts Medical
Center. “As a physician, this is exciting. Vitiligo has
historically been challenging to treat, and these data reinforce
the potential that this new medical treatment can have for people
who are interested in repigmentation.”
Vitiligo is a chronic autoimmune disease characterized by
depigmentation of skin that results from the loss of
pigment-producing cells known as melanocytes. Overactivity of the
JAK signaling pathway is believed to drive inflammation involved in
the pathogenesis and progression of vitiligo. In the United States,
more than 1.5 million people are diagnosed with vitiligo3. The
overall prevalence of the condition is estimated to be
approximately 2-3 million4, with the majority of patients
(approximately 85%) suffering from nonsegmental vitiligo5. Vitiligo
can occur at any age, although many patients with vitiligo will
experience initial onset before the age of 306.
In July 2022, Opzelura (ruxolitinib) cream was approved by the
FDA for the topical treatment of nonsegmental vitiligo in adult and
pediatric patients 12 years of age and older. Previously, in 2021,
Opzelura was approved by the FDA for the topical short-term and
non-continuous chronic treatment of mild to moderate atopic
dermatitis (AD) in non-immunocompromised patients 12 years of age
and older whose disease is not adequately controlled with topical
prescription therapies, or when those therapies are not
advisable.
The NEJM publication of the TRuE-V results is available
online.
About TRuE-V
The TRuE-V clinical trial program includes two Phase 3 studies,
TRuE-V1 (NCT04052425) and TRuE-V2 (NCT04057573), evaluating the
safety and efficacy of ruxolitinib cream in patients with vitiligo.
Each study enrolled approximately 300 patients (age ≥12 years) who
have been diagnosed with nonsegmental vitiligo.
About Opzelura™ (ruxolitinib) Cream 1.5%
Opzelura, a novel cream formulation of Incyte’s selective
JAK1/JAK2 inhibitor ruxolitinib approved by the U.S. Food &
Drug Administration for the topical treatment of nonsegmental
vitiligo in patients 12 years of age and older, is the first and
only treatment for repigmentation approved for use in the United
States. Opzelura is also approved in the U.S. for the topical
short-term and non-continuous chronic treatment of mild to moderate
atopic dermatitis (AD) in non-immunocompromised patients 12 years
of age and older whose disease is not adequately controlled with
topical prescription therapies, or when those therapies are not
advisable. Use of Opzelura in combination with therapeutic
biologics, other JAK inhibitors, or potent immunosuppressants, such
as azathioprine or cyclosporine, is not recommended.
The marketing authorization application (MAA) for ruxolitinib
cream as a potential treatment for adolescents and adults (age
>12 years) with nonsegmental vitiligo with facial involvement is
under review at the European Medicines Agency (EMA).
Incyte has worldwide rights for the development and
commercialization of ruxolitinib cream, marketed in the United
States as Opzelura. In April 2022, Incyte entered into a strategic
alliance agreement with Maruho Co., Ltd. for the development,
manufacturing and exclusive commercialization of ruxolitinib cream
for treatment of autoimmune and inflammatory dermatology
indications in Japan.
Opzelura is a trademark of Incyte.
IMPORTANT SAFETY INFORMATION
OPZELURA is for use on the skin only. Do not use OPZELURA in
your eyes, mouth, or vagina.
OPZELURA may cause serious side effects, including:
Serious Infections: OPZELURA contains ruxolitinib.
Ruxolitinib belongs to a class of medicines called Janus kinase
(JAK) inhibitors. JAK inhibitors are medicines that affect your
immune system. JAK inhibitors can lower the ability of your immune
system to fight infections. Some people have had serious infections
while taking JAK inhibitors by mouth, including tuberculosis (TB),
and infections caused by bacteria, fungi, or viruses that can
spread throughout the body. Some people have been hospitalized or
died from these infections. Some people have had serious infections
of their lungs while taking OPZELURA. Your healthcare provider
should watch you closely for signs and symptoms of TB during
treatment with OPZELURA.
OPZELURA should not be used in people with an active, serious
infection, including localized infections. You should not start
using OPZELURA if you have any kind of infection unless your
healthcare provider tells you it is okay. You may be at a higher
risk of developing shingles (herpes zoster) while using
OPZELURA.
Increased risk of death due to any reason (all causes):
Increased risk of death has happened in people 50 years of age and
older who have at least 1 heart disease (cardiovascular) risk
factor and are taking a medicine in the class of medicines called
JAK inhibitors by mouth.
Cancer and immune system problems: OPZELURA may increase
your risk of certain cancers by changing the way your immune system
works. Lymphoma and other cancers have happened in people taking a
medicine in the class of medicines called JAK inhibitors by mouth.
People taking JAK inhibitors by mouth have a higher risk of certain
cancers including lymphoma and lung cancer, especially if they are
a current or past smoker. Some people have had skin cancers while
using OPZELURA. Your healthcare provider will regularly check your
skin during your treatment with OPZELURA. Limit the amount of time
you spend in the sunlight. Wear protective clothing when you are in
the sun and use a broad-spectrum sunscreen.
Increased risk of major cardiovascular events: Increased
risk of major cardiovascular events such as heart attack, stroke,
or death have happened in people 50 years of age and older who have
at least 1 heart disease (cardiovascular) risk factor and taking a
medicine in the class of medicines called JAK inhibitors by mouth,
especially in current or past smokers.
Blood clots: Blood clots in the veins of your legs (deep
vein thrombosis, DVT) or lungs (pulmonary embolism, PE) can happen
in some people taking OPZELURA. This may be life-threatening. Blood
clots in the vein of the legs (deep vein thrombosis, DVT) and lungs
(pulmonary embolism, PE) have happened more often in people who are
50 years of age and older and with at least 1 heart disease
(cardiovascular) risk factor taking a medicine in the class of
medicines called JAK inhibitors by mouth.
Low blood cell counts: OPZELURA may cause low platelet
counts (thrombocytopenia), low red blood cell counts (anemia), and
low white blood cell counts (neutropenia). If needed, your
healthcare provider will do a blood test to check your blood cell
counts during your treatment with OPZELURA and may stop your
treatment if signs or symptoms of low blood cell counts happen.
Cholesterol increases: Cholesterol increase has happened
in people when ruxolitinib is taken by mouth. Tell your healthcare
provider if you have high cholesterol or triglycerides.
Before starting OPZELURA, tell your healthcare provider if
you:
- have an infection, are being treated for one, or have had an
infection that does not go away or keeps coming back
- have diabetes, chronic lung disease, HIV, or a weak immune
system
- have TB or have been in close contact with someone with TB
- have had shingles (herpes zoster)
- have or have had hepatitis B or C
- live, have lived in, or have traveled to certain parts of the
country (such as the Ohio and Mississippi River valleys and the
Southwest) where there is an increased chance for getting certain
kinds of fungal infections. These infections may happen or become
more severe if you use OPZELURA. Ask your healthcare provider if
you do not know if you have lived in an area where these infections
are common.
- think you have an infection or have symptoms of an infection
such as: fever, sweating, or chills, muscle aches, cough or
shortness of breath, blood in your phlegm, weight loss, warm, red,
or painful skin or sores on your body, diarrhea or stomach pain,
burning when you urinate or urinating more often than usual,
feeling very tired
- have ever had any type of cancer, or are a current or past
smoker
- have had a heart attack, other heart problems, or a stroke
- have had blood clots in the veins of your legs or lungs in the
past
- have high cholesterol or triglycerides
- have or have had low white or red blood cell counts
- are pregnant or plan to become pregnant. It is not known if
OPZELURA will harm your unborn baby. There is a pregnancy exposure
registry for individuals who use OPZELURA during pregnancy. The
purpose of this registry is to collect information about the health
of you and your baby. If you become exposed to OPZELURA during
pregnancy, you and your healthcare provider should report exposure
to Incyte Corporation at 1-855-463-3463.
- are breastfeeding or plan to breastfeed. It is not known if
OPZELURA passes into your breast milk. Do not breastfeed during
treatment with OPZELURA and for about 4 weeks after the last
dose.
After starting OPZELURA:
- Call your healthcare provider right away if you have any
symptoms of an infection. OPZELURA can make you more likely to get
infections or make worse any infections that you have.
- Get emergency help right away if you have any symptoms of a
heart attack or stroke while using OPZELURA, including:
- discomfort in the center of your chest that lasts for more than
a few minutes, or that goes away and comes back
- severe tightness, pain, pressure, or heaviness in your chest,
throat, neck, or jaw
- pain or discomfort in your arms, back, neck, jaw, or
stomach
- shortness of breath with or without chest discomfort
- breaking out in a cold sweat
- nausea or vomiting
- feeling lightheaded
- weakness in one part or on one side of your body
- slurred speech
- Tell your healthcare provider right away if you have any signs
and symptoms of blood clots during treatment with OPZELURA,
including: swelling, pain, or tenderness in one or both legs,
sudden, unexplained chest or upper back pain, or shortness of
breath or difficulty breathing.
- Tell your healthcare provider right away if you develop or have
worsening of any symptoms of low blood cell counts, such as:
unusual bleeding, bruising, tiredness, shortness of breath, or
fever.
Tell your healthcare provider about all the medicines you take,
including prescription and over-the-counter medicines, vitamins,
and herbal supplements.
The most common side effects of OPZELURA in people treated
for atopic dermatitis include: common cold (nasopharyngitis),
diarrhea, bronchitis, ear infection, increase in a type of white
blood cell (eosinophil) count, hives, inflamed hair pores
(folliculitis), swelling of the tonsils (tonsillitis), and runny
nose (rhinorrhea).
The most common side effects of OPZELURA in people treated
for nonsegmental vitiligo include: acne at the application
site, itching at the application site, common cold
(nasopharyngitis), headache, urinary tract infection, redness at
the application site, and fever.
These are not all of the possible side effects of OPZELURA. Call
your doctor for medical advice about side effects. You may report
side effects to FDA at 1-800-FDA-1088. You may also report side
effects to Incyte Corporation at 1-855-463-3463.
Please see the Full Prescribing Information, including Boxed
Warning, and Medication Guide for OPZELURA.
INDICATIONS AND USAGE
OPZELURA is a prescription medicine used on the skin (topical)
for:
- short-term and non-continuous chronic treatment of mild to
moderate eczema (atopic dermatitis) in non-immunocompromised adults
and children 12 years of age and older whose disease is not well
controlled with topical prescription therapies or when those
therapies are not recommended
- the treatment of a type of vitiligo called nonsegmental
vitiligo in adults and children 12 years of age and older
The use of OPZELURA along with therapeutic biologics, other JAK
inhibitors, or strong immunosuppressants such as azathioprine or
cyclosporine is not recommended.
It is not known if OPZELURA is safe and effective in children
less than 12 years of age with atopic dermatitis or nonsegmental
vitiligo.
About Incyte Dermatology
Incyte’s science-first approach and expertise in immunology has
formed the foundation of the company. In Dermatology, the Company’s
research and development efforts are focused on leveraging our
knowledge of the JAK-STAT pathway to identify and develop topical
and oral therapies with the potential to modulate immune pathways
driving uncontrolled inflammation and help restore normal immune
function.
Currently, Incyte is exploring the potential of JAK inhibition
for additional immune-mediated dermatologic conditions with a high
unmet medical need, including hidradenitis suppurativa. To learn
more, visit the Dermatology section of Incyte.com.
About Incyte
Incyte is a Wilmington, Delaware-based, global biopharmaceutical
company focused on finding solutions for serious unmet medical
needs through the discovery, development and commercialization of
proprietary therapeutics. For additional information on Incyte,
please visit Incyte.com and follow @Incyte.
Forward-Looking Statements
Except for the historical information set forth herein, the
matters set forth in this press release, including statements
regarding whether and when Opzelura might provide a successful
treatment option for patients with vitiligo, Incyte’s TRuE-V
clinical program and Incyte’s Dermatology program generally,
contain predictions, estimates and other forward-looking
statements.
These forward-looking statements are based on the Company’s
current expectations and subject to risks and uncertainties that
may cause actual results to differ materially, including
unanticipated developments in and risks related to: unanticipated
delays; further research and development and the results of
clinical trials possibly being unsuccessful or insufficient to meet
applicable regulatory standards or warrant continued development;
the ability to enroll sufficient numbers of subjects in clinical
trials; the effects of the COVID-19 pandemic and measures to
address the pandemic on the Company’s clinical trials, supply
chain, other third-party providers and development and discovery
operations; determinations made by the FDA and other regulatory
authorities; the efficacy or safety of the Company’s products; the
acceptance of the Company’s products in the marketplace; market
competition; sales, marketing, manufacturing and distribution
requirements; and other risks detailed from time to time in the
Company’s reports filed with the Securities and Exchange
Commission, including its annual report and its quarterly report on
Form 10-Q for the quarter ended June 30, 2022. The Company
disclaims any intent or obligation to update these forward-looking
statements.
__________________________________
1 Rosmarin D, et al. Two Phase 3
Randomized Controlled Trials of Ruxolitinib Cream for Vitiligo. N
Engl J Med. 2022; 387:1445-1455.
2 Opzelura Prescribing Information.
Wilmington, DE. Incyte Corporation.
3 Bergqvist C, Ezzedine K. Vitiligo: A
Review. Dermatology. 2020;236:571-592.
4 Gandhi K, et al. Prevalence of vitiligo
among adults in the United States. JAMA Dermatol.
2022;158(1):43-50.
5 Ezzedine K, et al. Seminar: Vitiligo.
Lancet. 2015;386:74–84.
6 Frisoli M, et al. Vitiligo: mechanisms
of pathogenesis and treatment. Annu. Rev. Immunol.
2020;38(1):621-648.
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